This week, Medicines Australia (MA) released its latest Code of Conduct report detailing finalised complaints about the promotion of prescription medicines for July – December 2006. It’s available at: http://www.medicinesaustralia.com.au/pages/page30.asp

Twelve companies attracted 20 complaints; 13 of which were upheld by MSA’s independent Code of Conduct committee. As usual, most complaints were submitted by pharmaceutical companies.

Bayer’s product Levitra (vardenafil) received four upheld complaints about a money back guarantee campaign which aimed to stimulate consumers to seek prescriptions for their product. Sanctions applied included an order to cease offering the money back guarantee, sending a corrective letter to healthcare professionals who had received the material and inserting a corrective advertisement in all healthcare professional journals where the offending advertisement had appeared.

Schering’s product Betaferon (interferon beta-1b) attracted two upheld complaints for promoting unapproved indications and promoting a prescription product to the general public. Sanctions included the recall of promotional material, corrective letters and fines of $150,000
and $100,000 respectively.

Roche attracted upheld complaints about excessive hospitality which included a dinner for 200 cancer specialists at the Sydney Opera House Bennelong restaurant costing more than $200 a head. They were fined $75,000.

AstraZeneca’s product Crestor (rosuvastatin) attracted an upheld complaint for promoting false and misleading claims. Sanctions applied included an order to send a corrective letter to healthcare
professionals who had received the offending material and a fine of $75,000

Sanctions applied to other companies with upheld complaints included orders for corrective letters and fines ranging from $25,000 to $10,000. Both Medicines Australia and the government argue that the outcomes detailed above show that self-regulatory Codes of Conduct are working.
Others disagree.

Finalised Code complaint reports show that some companies have been associated with repeated code breaches over many years, despite the sanctions applied by Medicines Australia. The maximum fine that can be imposed by Medicines Australia is $200,000; a minuscule amount compared
to the profit that can be generated from “creative” promotional campaigns. Contrast Medicines Australia fines with those of the US Federal Trade Commission. The latter recently settled allegations that the claims of four weight loss products were not supported by competent
and reliable scientific evidence by recovering US $25 million from the offending companies, as well as limiting their future advertising claims. See: http://www.ftc.gov/opa/2007/01/weightloss.htm

In addition, by the time complaints and appeals have been heard by Medicines Australia the offending promotional campaign has usually run its course. While corrective letters and advertising orders are useful they do not undo the damage done before they were invoked.

Finally, the motivation of drug companies who complain is more likely to be an attempt to stymie advertising campaigns by their competitors rather than any concern over what misleading ads might do to health professionals or the public. It also takes time and effort to complain which is why few complaints come from health professionals or consumers.

So what should be done to improve the system. First, the responsibility to hear complaints should be taken out of the hands of an industry association and given to a representative independent committee involving all stakeholders under the auspices of the Therapeutic Goods Administration. Second, fines for serious and repeated breaches should be increased to US levels and the money gained used for education of health professionals and consumers via the National Prescribing Service
and other organisations. Third, prospective monitoring of promotional campaigns should be contracted out to appropriate bodies such as Healthy Skepticism Inc., see: http://www.healthyskepticism.org. Finally, post-marketing promotional surveillance and complaint procedures for all medicines: prescription, OTC and complementary should be handled by one
body, not the multitude of industry self-regulatory and other bodies currently involved:

I find the Healthy Skepticism Updates extremely useful and I open many of the links with interest.
- Tom Perry MD, Vancouver

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